Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
5
hematologic malignancies ; acute myeloid leukemias
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Feb 2022 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516104-42-00
- EudraCT number
- 2019-004883-23
- ClinicalTrials.gov
- NCT03879876
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
hematologic malignancies ; acute myeloid leukemias
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Olivier Hermine
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Olivier Hermine
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
75, 149 Rue De Sevres, 75015, Paris
Institut Gustave Roussy
94, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
75, Porte 23, 1 Avenue Claude Vellefaux, Paris Cedex 10
CHU De Bordeaux
33, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Universitaire De Toulouse
31, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-02-17 | 2022-02-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | France | Acceptable 2024-08-20
|
2024-08-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-11 | France | Acceptable 2024-08-20
|
2025-07-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-07-03 | France | Acceptable 2024-08-20
|
2026-07-03 |